Oral Nicotine Replacement Rules

Summary#

The Supplementary Rules Respecting Nicotine Replacement Therapies Order adds new rules for certain orally taken nicotine replacement therapies (NRTs). It aims to reduce youth appeal and access by restricting flavours, labelling, advertising, and where some products can be sold. The order is made under the Food and Drugs Act and came into force on publication in the Canada Gazette (August 28, 2024).

What it does#

• Requires companies to send mock-ups of all product labels and packages when applying for or amending a licence for an oral NRT.
• Forces licence-holders to submit a formal amendment (not just a notification) if they change a product’s brand name or switch non-medicinal ingredients that affect flavour.
• Limits which NRT forms can be sold for self-selection (left on store shelves) by referring to the government List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers. Forms not on that List (for example, nicotine pouches and some rapid-dissolving tablets) must be sold only by a pharmacist or someone under a pharmacist’s supervision and kept out of general self-selection.
• Bans certain flavours:
  • For dosage forms not on the List: only mint, menthol, or a combination of those are allowed.
  • For dosage forms on the List: dessert, confectionery, soft drink, and energy drink flavours are prohibited.
• Tightens brand, label, and package rules so names, graphics or statements cannot be misleading, appealing to young people, or look like food or cannabis.
• Requires clear labelling on the outer label (in both official languages) that the product is for adults and must display the warning “WARNING: Nicotine is highly addictive.” on the principal display panel.
• Restricts advertising so NRTs can only be promoted for smoking cessation, must include specific intended-use and warning statements, and cannot be presented in ways that could appeal to young people.
• Gives a transition period of 6 months after the order’s coming into force for many labelling and advertising changes, but place-of-sale and flavour limits take effect immediately for the affected dosage forms.
• Lets Health Canada use existing compliance powers (including licence suspension or stop-sale orders) to enforce the rules.

Who's affected#

• NRT manufacturers, importers, packagers and labellers (they must redesign labels, submit mock-ups, and possibly reformulate flavours).
• Retailers and distributors, including convenience stores, gas stations, grocery stores and pharmacies (some products will move behind the pharmacy counter or stop being sold outside pharmacies).
• Pharmacists and their staff (they will supervise sales for certain dosage forms and may spend extra time advising customers).
• Consumers:
  • Adults trying to quit smoking (access to many NRTs for cessation is intended to be maintained).
  • Young people (defined in the order as under 18 years) — the rules are aimed at reducing their access and exposure.
• Health Canada (will review more label/package mock-ups and oversee compliance).
  If it’s unclear who exactly will be affected for a particular product, the order lets Health Canada update the public List over time.

Why it matters#

• The government says some oral NRTs (like pouches) and their flavours, packaging or advertising can attract people who are not trying to quit — especially young people. The order is intended to lower that appeal and reduce unintended nicotine exposure and addiction in youth.
• It balances tighter limits on some new or emerging product types with continued access to traditional NRTs (like gum and lozenges) for adults trying to quit.
• The regulatory impact analysis estimates total compliance costs of about $92.97 million (present value) over 10 years, or $13.24 million per year. These are mostly costs to industry for relabelling, reformulating flavours, moving products to pharmacy-only sale, and submitting mock-ups. Health and access impacts are expected to be positive for young people, though some consumers (especially those in remote areas) and some retailers may face inconvenience.
• The order is already in effect on publication (August 28, 2024) and includes a 6-month transition window for many labelling and advertising changes, so manufacturers and sellers will need to act quickly.